Schizophrenia
Conditions
Keywords
Schizophrenia, Paliperidone Palmitate, JNS010
Brief summary
The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
Detailed description
This is a multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), parallel-group (Each group of participants will be treated at the same time), comparison study to assess the pharmacokinetics and safety of paliperidone palmitate (study medication) in participants with schizophrenia. The study comprises a 64-day Treatment period and a 155-day Follow-up period. The participants will be randomly assigned to one of the four study groups. The study medication will be administered on Days 1, 8, 36 and 64. Pharmacokinetics of the study medication will be assessed as primary outcome. Participants' safety will be monitored throughout the study.
Interventions
DRUGPaliperidone palmitate
Paliperidone palmitate aqueous suspension for injection 0.5, 1.0, 1.5 milliliter equivalent to 50, 100, 150 mg paliperidone respectively as intramuscular injection on Days 1, 8, 36 and 64.
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants who have been diagnosed with schizophrenia in accordance with the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) * Participants may be inpatients or outpatients * Participants who have been taking an oral antipsychotic medication for at least 28 days before the date of informed consent * Participants with a Positive and Negative Syndrome Scale (PANSS) score of less than or equal to 4 (moderate) at screening * Participants who have taken risperidone by the start of investigational treatment and the record can be confirmed
Exclusion criteria
* Participants who have been diagnosed with a mental disease other than schizophrenia in accordance with the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) * Participants who have been diagnosed with substance-related disorders (except nicotine and caffeine dependence) * Participants with complicated parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is muscle weakness, trembling and sweating) * Participants with a complication of or with a history of convulsive disease such as epilepsy (seizure disorder) * Participants with a complication of or with a history of cerebro-vascular accident (stroke), neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness) or physical exhaustion associated with the state of dehydration (lose of water and minerals in the body) or malnutrition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218 | Day 218 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]). |
| Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120 | Day 120 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]). |
| Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162 | Day 162 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]). |
| Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8 | Day 8 | The pre-dose plasma concentration (Cpredose) at Day 8 is defined as the plasma concentration obtained before a dose is given on Day 8. The mean Cpredose at Day 8 was measured in nanogram per milliliter (ng/ml). |
| Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36 | Day 36 | The Cpredose at Day 36 is defined as the plasma concentration obtained before a dose is given on Day 36. The mean Cpredose at Day 36 was measured in ng/ml. |
| Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64 | Day 64 | The Cpredose at Day 64 is defined as the plasma paliperidone concentration obtained before a dose is given on Day 64. The mean Cpredose at Day 64 was measured in ng/ml. |
| Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92 | Day 92 | The Cpredose at Day 92 is defined as the plasma paliperidone concentration obtained after the treatment interval of the study drug (that is 4 weeks) passed after the final dose (Day 92). The mean Cpredose at Day 92 was measured in ng/ml. |
| Maximum Observed Plasma Concentration (Cmax) of Paliperidone | Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal | The Cmax is defined as maximum observed analyte concentration. |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone | Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal | The AUCtau is a measure of the plasma paliperidone concentration from time zero to end of dosing interval. It is used to characterize drug absorption. |
| Plasma Paliperidone Concentration at Steady State (Css av) | Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal | The Css av is defined as value of average analyte concentration at steady-state (after 4 Intramuscular Injections of Paliperidone Palmitate). |
| Paliperidone Plasma Decay Half-Life (t1/2) | Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8 | Day 8 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]). |
| Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22 | Day 22 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]). |
| Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50 | Day 50 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]). |
| Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78 | Day 78 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]). |
| Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92 | Day 92 | The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Day 8, 22, 50, 78 and 92 | The CGI-S rating scale is a 7 point (1-absent, 2-minimal, 3-mild, 4-moderate, 5-moderate severe, 6-severe, 7-extreme) global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher scores indicate worsening. |
| Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline, Day 8, 22, 50, 78 and 92 | The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paliperidone Palmitate 50 mg Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64. | 14 |
| Paliperidone Palmitate 100 mg Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64. | 14 |
| Paliperidone Palmitate 150 mg Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64. | 14 |
| Paliperidone Palmitate 150/ 50 mg Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64. | 14 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 0 | 2 |
Baseline characteristics
| Characteristic | Paliperidone Palmitate 50 mg | Paliperidone Palmitate 100 mg | Paliperidone Palmitate 150 mg | Paliperidone Palmitate 150/ 50 mg | Total |
|---|---|---|---|---|---|
| Age Continuous | 46.4 Years STANDARD_DEVIATION 13.8 | 45.2 Years STANDARD_DEVIATION 11.1 | 48.7 Years STANDARD_DEVIATION 11.8 | 49.4 Years STANDARD_DEVIATION 12.1 | 47.4 Years STANDARD_DEVIATION 12 |
| Number of Participants with Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score Mild | 0 Participant | 0 Participant | 1 Participant | 0 Participant | 1 Participant |
| Number of Participants with Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score None | 8 Participant | 8 Participant | 5 Participant | 5 Participant | 26 Participant |
| Number of Participants with Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score Very mild | 6 Participant | 6 Participant | 8 Participant | 9 Participant | 29 Participant |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants | 6 Participants | 16 Participants |
| Sex: Female, Male Male | 12 Participants | 9 Participants | 11 Participants | 8 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 14 | 14 / 14 | 14 / 14 | 14 / 14 |
| serious Total, serious adverse events | 1 / 14 | 0 / 14 | 2 / 14 | 3 / 14 |
Outcome results
Primary
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
The AUCtau is a measure of the plasma paliperidone concentration from time zero to end of dosing interval. It is used to characterize drug absorption.
Time frame: Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal
Population: Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | 7081 nanogram*hour per milliliter | Standard Deviation 3581 |
| Paliperidone Palmitate 100 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | 15898 nanogram*hour per milliliter | Standard Deviation 7535 |
| Paliperidone Palmitate 150 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | 21853 nanogram*hour per milliliter | Standard Deviation 15534 |
| Paliperidone Palmitate 150/ 50 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | 11109 nanogram*hour per milliliter | Standard Deviation 5390 |
Primary
Maximum Observed Plasma Concentration (Cmax) of Paliperidone
The Cmax is defined as maximum observed analyte concentration.
Time frame: Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal
Population: Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Maximum Observed Plasma Concentration (Cmax) of Paliperidone | 13.7 ng/ml | Standard Deviation 7.52 |
| Paliperidone Palmitate 100 mg | Maximum Observed Plasma Concentration (Cmax) of Paliperidone | 33.5 ng/ml | Standard Deviation 19.8 |
| Paliperidone Palmitate 150 mg | Maximum Observed Plasma Concentration (Cmax) of Paliperidone | 43.1 ng/ml | Standard Deviation 30.3 |
| Paliperidone Palmitate 150/ 50 mg | Maximum Observed Plasma Concentration (Cmax) of Paliperidone | 21.6 ng/ml | Standard Deviation 12.9 |
Primary
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
Time frame: Day 120
Population: Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120 | None | 9 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120 | Mild | 0 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120 | Very mild | 4 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120 | None | 6 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120 | Mild | 0 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120 | Very mild | 5 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120 | Very mild | 6 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120 | None | 6 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120 | Mild | 2 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120 | None | 6 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120 | Mild | 0 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120 | Very mild | 5 Participants |
Primary
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
Time frame: Day 162
Population: Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162 | None | 9 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162 | Mild | 0 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162 | Very mild | 3 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162 | None | 7 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162 | Mild | 0 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162 | Very mild | 4 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162 | Very mild | 6 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162 | None | 6 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162 | Mild | 2 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162 | None | 7 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162 | Mild | 0 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162 | Very mild | 4 Participants |
Primary
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
Time frame: Day 218
Population: Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218 | None | 9 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218 | Mild | 0 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218 | Very mild | 3 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218 | None | 7 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218 | Mild | 0 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218 | Very mild | 4 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218 | Very mild | 7 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218 | None | 6 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218 | Mild | 1 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218 | None | 6 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218 | Mild | 0 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218 | Very mild | 5 Participants |
Primary
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
Time frame: Day 22
Population: Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22 | None | 7 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22 | Mild | 0 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22 | Very mild | 7 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22 | None | 7 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22 | Mild | 0 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22 | Very mild | 6 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22 | Very mild | 7 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22 | None | 6 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22 | Mild | 1 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22 | None | 6 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22 | Mild | 0 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22 | Very mild | 8 Participants |
Primary
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
Time frame: Day 50
Population: Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50 | None | 11 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50 | Mild | 0 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50 | Very mild | 3 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50 | None | 7 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50 | Mild | 0 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50 | Very mild | 5 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50 | Very mild | 5 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50 | None | 8 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50 | Mild | 1 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50 | None | 6 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50 | Mild | 0 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50 | Very mild | 6 Participants |
Primary
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
Time frame: Day 78
Population: Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78 | None | 9 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78 | Mild | 0 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78 | Very mild | 4 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78 | None | 8 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78 | Mild | 0 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78 | Very mild | 4 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78 | Very mild | 5 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78 | None | 8 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78 | Mild | 1 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78 | None | 6 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78 | Mild | 0 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78 | Very mild | 5 Participants |
Primary
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
Time frame: Day 8
Population: Safety analysis set included all participants who were enrolled in the study and received the study medication at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8 | None | 6 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8 | Mild | 0 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8 | Very mild | 8 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8 | None | 9 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8 | Mild | 0 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8 | Very mild | 5 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8 | Very mild | 6 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8 | None | 6 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8 | Mild | 2 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8 | None | 6 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8 | Mild | 1 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8 | Very mild | 7 Participants |
Primary
Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
Time frame: Day 92
Population: Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92 | None | 7 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92 | Mild | 0 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92 | Very mild | 6 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92 | None | 7 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92 | Mild | 0 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92 | Very mild | 5 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92 | Very mild | 6 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92 | None | 7 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92 | Mild | 1 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92 | None | 5 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92 | Mild | 0 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92 | Very mild | 6 Participants |
Primary
Paliperidone Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal
Population: Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Paliperidone Plasma Decay Half-Life (t1/2) | 68.1 Days | Standard Deviation 48 |
| Paliperidone Palmitate 100 mg | Paliperidone Plasma Decay Half-Life (t1/2) | 58.5 Days | Standard Deviation 29.1 |
| Paliperidone Palmitate 150 mg | Paliperidone Plasma Decay Half-Life (t1/2) | 95.5 Days | Standard Deviation 98.8 |
| Paliperidone Palmitate 150/ 50 mg | Paliperidone Plasma Decay Half-Life (t1/2) | 104.4 Days | Standard Deviation 97.1 |
Primary
Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36
The Cpredose at Day 36 is defined as the plasma concentration obtained before a dose is given on Day 36. The mean Cpredose at Day 36 was measured in ng/ml.
Time frame: Day 36
Population: Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36 | 6.77 ng/ml | Standard Deviation 3.75 |
| Paliperidone Palmitate 100 mg | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36 | 14.5 ng/ml | Standard Deviation 5.76 |
| Paliperidone Palmitate 150 mg | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36 | 23.4 ng/ml | Standard Deviation 18.6 |
| Paliperidone Palmitate 150/ 50 mg | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36 | 19.5 ng/ml | Standard Deviation 16.1 |
Primary
Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64
The Cpredose at Day 64 is defined as the plasma paliperidone concentration obtained before a dose is given on Day 64. The mean Cpredose at Day 64 was measured in ng/ml.
Time frame: Day 64
Population: Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64 | 6.86 ng/ml | Standard Deviation 3.31 |
| Paliperidone Palmitate 100 mg | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64 | 15.1 ng/ml | Standard Deviation 9.16 |
| Paliperidone Palmitate 150 mg | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64 | 22.9 ng/ml | Standard Deviation 16.3 |
| Paliperidone Palmitate 150/ 50 mg | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64 | 14.3 ng/ml | Standard Deviation 9.01 |
Primary
Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8
The pre-dose plasma concentration (Cpredose) at Day 8 is defined as the plasma concentration obtained before a dose is given on Day 8. The mean Cpredose at Day 8 was measured in nanogram per milliliter (ng/ml).
Time frame: Day 8
Population: Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8 | 5.85 ng/ml | Standard Deviation 4.47 |
| Paliperidone Palmitate 100 mg | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8 | 7.28 ng/ml | Standard Deviation 4.92 |
| Paliperidone Palmitate 150 mg | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8 | 28.4 ng/ml | Standard Deviation 29.2 |
| Paliperidone Palmitate 150/ 50 mg | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8 | 12.1 ng/ml | Standard Deviation 7.46 |
Primary
Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92
The Cpredose at Day 92 is defined as the plasma paliperidone concentration obtained after the treatment interval of the study drug (that is 4 weeks) passed after the final dose (Day 92). The mean Cpredose at Day 92 was measured in ng/ml.
Time frame: Day 92
Population: Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92 | 8.41 ng/ml | Standard Deviation 4.51 |
| Paliperidone Palmitate 100 mg | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92 | 15.2 ng/ml | Standard Deviation 6.21 |
| Paliperidone Palmitate 150 mg | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92 | 25.4 ng/ml | Standard Deviation 16.8 |
| Paliperidone Palmitate 150/ 50 mg | Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92 | 13.5 ng/ml | Standard Deviation 6.38 |
Primary
Plasma Paliperidone Concentration at Steady State (Css av)
The Css av is defined as value of average analyte concentration at steady-state (after 4 Intramuscular Injections of Paliperidone Palmitate).
Time frame: Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal
Population: Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Plasma Paliperidone Concentration at Steady State (Css av) | 10.7 ng/ml | Standard Deviation 5.42 |
| Paliperidone Palmitate 100 mg | Plasma Paliperidone Concentration at Steady State (Css av) | 23.9 ng/ml | Standard Deviation 11.4 |
| Paliperidone Palmitate 150 mg | Plasma Paliperidone Concentration at Steady State (Css av) | 32.8 ng/ml | Standard Deviation 23.1 |
| Paliperidone Palmitate 150/ 50 mg | Plasma Paliperidone Concentration at Steady State (Css av) | 16.7 ng/ml | Standard Deviation 8.28 |
Primary
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Time frame: Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal
Population: Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paliperidone Palmitate 50 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone | 10.99 Days |
| Paliperidone Palmitate 100 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone | 7.89 Days |
| Paliperidone Palmitate 150 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone | 7.50 Days |
| Paliperidone Palmitate 150/ 50 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone | 3.82 Days |
Secondary
Number of Participants With Clinical Global Impression Severity (CGI-S) Score
The CGI-S rating scale is a 7 point (1-absent, 2-minimal, 3-mild, 4-moderate, 5-moderate severe, 6-severe, 7-extreme) global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher scores indicate worsening.
Time frame: Baseline, Day 8, 22, 50, 78 and 92
Population: The PPS included all participants who were enrolled in the study, received study medication at least once and had at least one efficacy evaluation. LOCF imputation method was used. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 8, Moderate (n=14,14,13,14) | 3 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Mild (n=14,14,14,14) | 8 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Moderate (n=14,14,14,14) | 3 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Moderate severe (n=14,14,14,14) | 0 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 8, Minimal (n=14,14,13,14) | 3 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 8, Mild (n=14,14,13,14) | 8 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Minimal (n=14,14,14,14) | 3 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 8, Moderate severe (n=14,14,13,14) | 0 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 22, Minimal (n=14,14,14,14) | 4 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 22, Mild (n=14,14,14,14) | 8 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 22, Moderate (n=14,14,14,14) | 2 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 22, Moderate severe (n=14,14,14,14) | 0 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 50, Minimal (n=14,14,14,14) | 5 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 50, Mild (n=14,14,14,14) | 7 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 50, Moderate (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 50, Moderate severe (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 78, Minimal (n=14,14,14,14) | 6 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 78, Mild (n=14,14,14,14) | 6 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 78, Moderate (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 78, Moderate severe (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 92, Minimal (n=14,14,14,14) | 5 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 92, Mild(n=14,14,14,14) | 7 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 92, Moderate (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 92, Moderate severe (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 92, Moderate severe (n=14,14,14,14) | 2 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 50, Minimal (n=14,14,14,14) | 5 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Moderate severe (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 92, Moderate (n=14,14,14,14) | 3 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 92, Mild(n=14,14,14,14) | 5 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 50, Mild (n=14,14,14,14) | 4 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 22, Minimal (n=14,14,14,14) | 5 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 78, Minimal (n=14,14,14,14) | 5 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 8, Mild (n=14,14,13,14) | 7 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 50, Moderate (n=14,14,14,14) | 3 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Moderate (n=14,14,14,14) | 3 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 50, Moderate severe (n=14,14,14,14) | 2 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 92, Minimal (n=14,14,14,14) | 4 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 22, Mild (n=14,14,14,14) | 5 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 78, Moderate severe (n=14,14,14,14) | 2 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Mild (n=14,14,14,14) | 6 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 8, Moderate severe (n=14,14,13,14) | 2 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 22, Moderate (n=14,14,14,14) | 3 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 8, Moderate (n=14,14,13,14) | 2 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 78, Moderate (n=14,14,14,14) | 3 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Minimal (n=14,14,14,14) | 4 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 22, Moderate severe (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 8, Minimal (n=14,14,13,14) | 3 Participants |
| Paliperidone Palmitate 100 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 78, Mild (n=14,14,14,14) | 4 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 22, Moderate (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 8, Moderate (n=14,14,13,14) | 1 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 8, Moderate severe (n=14,14,13,14) | 0 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 22, Minimal (n=14,14,14,14) | 4 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 22, Mild (n=14,14,14,14) | 9 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 92, Minimal (n=14,14,14,14) | 5 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 78, Moderate severe (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 22, Moderate severe (n=14,14,14,14) | 0 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 50, Minimal (n=14,14,14,14) | 3 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 50, Mild (n=14,14,14,14) | 10 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 92, Mild(n=14,14,14,14) | 8 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 50, Moderate (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 50, Moderate severe (n=14,14,14,14) | 0 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 92, Moderate severe (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 78, Minimal (n=14,14,14,14) | 5 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 78, Mild (n=14,14,14,14) | 8 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 92, Moderate (n=14,14,14,14) | 0 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Minimal (n=14,14,14,14) | 3 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Mild (n=14,14,14,14) | 10 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 78, Moderate (n=14,14,14,14) | 0 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Moderate (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Moderate severe (n=14,14,14,14) | 0 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 8, Minimal (n=14,14,13,14) | 3 Participants |
| Paliperidone Palmitate 150 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 8, Mild (n=14,14,13,14) | 9 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 92, Moderate (n=14,14,14,14) | 2 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 92, Minimal (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 8, Moderate severe (n=14,14,13,14) | 0 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Minimal (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 22, Moderate (n=14,14,14,14) | 3 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 22, Mild (n=14,14,14,14) | 9 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 8, Mild (n=14,14,13,14) | 10 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Mild (n=14,14,14,14) | 8 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 8, Minimal (n=14,14,13,14) | 1 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 22, Minimal (n=14,14,14,14) | 2 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 78, Moderate severe (n=14,14,14,14) | 0 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Moderate (n=14,14,14,14) | 5 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 92, Mild(n=14,14,14,14) | 11 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 50, Moderate (n=14,14,14,14) | 0 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 78, Moderate (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 50, Moderate severe (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 92, Moderate severe (n=14,14,14,14) | 0 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 50, Mild (n=14,14,14,14) | 13 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 8, Moderate (n=14,14,13,14) | 3 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 78, Minimal (n=14,14,14,14) | 1 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 50, Minimal (n=14,14,14,14) | 0 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 22, Moderate severe (n=14,14,14,14) | 0 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Baseline, Moderate severe (n=14,14,14,14) | 0 Participants |
| Paliperidone Palmitate 150/ 50 mg | Number of Participants With Clinical Global Impression Severity (CGI-S) Score | Day 78, Mild (n=14,14,14,14) | 12 Participants |
Secondary
Positive and Negative Syndrome Scale (PANSS) Total Score
The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).
Time frame: Baseline, Day 8, 22, 50, 78 and 92
Population: Per protocol set (PPS) included all participants who were enrolled in the study, received study medication at least once and had at least one efficacy evaluation. Last observation carried forward (LOCF) imputation method was used. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Palmitate 50 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline (n = 14, 14, 14, 14) | 61.9 units on a scale | Standard Deviation 12.39 |
| Paliperidone Palmitate 50 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 8 (n = 14, 14, 13, 14) | 60.0 units on a scale | Standard Deviation 13.85 |
| Paliperidone Palmitate 50 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 22 (n = 14, 14, 14, 14) | 56.8 units on a scale | Standard Deviation 13.19 |
| Paliperidone Palmitate 50 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 50 (n = 14, 14, 14, 14) | 57.9 units on a scale | Standard Deviation 17.49 |
| Paliperidone Palmitate 50 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 78 (n = 14, 14, 14, 14) | 56.4 units on a scale | Standard Deviation 17.07 |
| Paliperidone Palmitate 50 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 92 (n = 14, 14, 14, 14) | 56.4 units on a scale | Standard Deviation 17.79 |
| Paliperidone Palmitate 100 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 92 (n = 14, 14, 14, 14) | 60.2 units on a scale | Standard Deviation 20.38 |
| Paliperidone Palmitate 100 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 50 (n = 14, 14, 14, 14) | 60.0 units on a scale | Standard Deviation 20.47 |
| Paliperidone Palmitate 100 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline (n = 14, 14, 14, 14) | 60.7 units on a scale | Standard Deviation 17.28 |
| Paliperidone Palmitate 100 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 22 (n = 14, 14, 14, 14) | 58.1 units on a scale | Standard Deviation 19.59 |
| Paliperidone Palmitate 100 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 8 (n = 14, 14, 13, 14) | 59.6 units on a scale | Standard Deviation 19.44 |
| Paliperidone Palmitate 100 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 78 (n = 14, 14, 14, 14) | 60.4 units on a scale | Standard Deviation 20.05 |
| Paliperidone Palmitate 150 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 8 (n = 14, 14, 13, 14) | 57.8 units on a scale | Standard Deviation 17.21 |
| Paliperidone Palmitate 150 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 22 (n = 14, 14, 14, 14) | 57.1 units on a scale | Standard Deviation 16.1 |
| Paliperidone Palmitate 150 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 50 (n = 14, 14, 14, 14) | 56.5 units on a scale | Standard Deviation 15.04 |
| Paliperidone Palmitate 150 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 92 (n = 14, 14, 14, 14) | 57.4 units on a scale | Standard Deviation 17.83 |
| Paliperidone Palmitate 150 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 78 (n = 14, 14, 14, 14) | 57.2 units on a scale | Standard Deviation 18.55 |
| Paliperidone Palmitate 150 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline (n = 14, 14, 14, 14) | 60.4 units on a scale | Standard Deviation 16.76 |
| Paliperidone Palmitate 150/ 50 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 78 (n = 14, 14, 14, 14) | 59.9 units on a scale | Standard Deviation 13.03 |
| Paliperidone Palmitate 150/ 50 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 92 (n = 14, 14, 14, 14) | 60.6 units on a scale | Standard Deviation 13.52 |
| Paliperidone Palmitate 150/ 50 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 8 (n = 14, 14, 13, 14) | 62.6 units on a scale | Standard Deviation 15.33 |
| Paliperidone Palmitate 150/ 50 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 50 (n = 14, 14, 14, 14) | 62.8 units on a scale | Standard Deviation 13.89 |
| Paliperidone Palmitate 150/ 50 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline (n = 14, 14, 14, 14) | 63.9 units on a scale | Standard Deviation 15.58 |
| Paliperidone Palmitate 150/ 50 mg | Positive and Negative Syndrome Scale (PANSS) Total Score | Day 22 (n = 14, 14, 14, 14) | 60.4 units on a scale | Standard Deviation 13.15 |